My question refers to the Validation Protocols and the subsequent Reports generated post execution.

Is it a requirement that the persons who approve the Qualification / Validation Protocols need to approve the Qualification / Validation reports after its execution ?

I have seen some organizations follow this practise but was trying to look for any guidance documents in this regard.

The answer is NO. There is no requirement for the same person to carry out these activities. Such a requirement would be extremely difficult to comply with, since, on large projects, there could be as much as a year between approving the protocols and completing the validation report.
The regulators specify that such persons must have the appropriate training for the tasks they do. The training records for all signatories must be held on file.
Alex Kennedy
Validation Online

Thanks Alex - but couple of big corporations that I worked earlier had this requirement :)

There is no requirement that the persons who approve the Qualification / Validation Protocols needs to approve the Qualification / Validation reports.

What we are practicing is :

The same level of approval as the original protocol is followed for the following cases.

a. If there is any amendment to the approved protocol, or
b. for the executed validation / qualification package approval.

Regards / Raghu

The correct answer is yes.

Even though there may not be a specific requirement for this you do want to evidence that the same functions involved on the creation of the validation protocol were also involved through execution of the validation, therefore the same persons that approved the opening protocol should also sign the validation closure report, sometimes this is not possible so a similar function should sign (i.e. a QE should sign for another QE. All this should be specified in your validation protocol.

The scope of validation requirements as set out in the various protocols is contained in the Validation Plan (VP). The VP is authored by a senior person who has the knowledge and ability to scope what the extent of the validation must be. In arriving at these requirements this person (s) will review all the associated documents and or specification (GMP, FS, DS, URS, Company Practices & Procedures and on). Once the VP is completed, reviewed by the appropriate staff, and authorised for use, it becomes the authority for your protocol content.

When you give the task of writing the protocols, to your protocol authors, you want them to know exactly what their terms of reference are. You do not want any of them trying to emulate Hemingway or Mark Twain. You want the protocols written strictly in accordance with your VP references. All your protocols must be subjected to reviews by different specialists (minimum of 3, maximum I have seen of 8) to ensure the content is as required, before they are approved for use. They then become official company documents.

In large corporations they often go to any of the company facilities (worldwide) and are executed there and form part of the regulatory records for that plant. So the original question was “is it a requirement that the same people who authorised the protocol must approve it on completion”. The answer is obviously no, nor is a requirement that it must be different people.

Alex Kennedy
Validation Online

Is it a requirement that the persons who approve the Qualification / Validation Protocols need to approve the Qualification / Validation reports after its execution ?

The answer is obviously no, nor is a requirement that it must be different people.

I'm confused with your lenghty answer in regards to the original question, so that would be "yes" which has already been stated?

Is there any reference of the protocol and report approval in any guidance documents ?